Can It Be True? Has Congress Finally Tracked Down a Federal Track-and-Trace System?

Over 25 years ago, the Prescription Drug Marketing Act ("PDMA") was passed. The PDMA called for implementation of a national system to follow prescription drugs through the supply chain. After years of talking about it (see here), and months of kicking the can down the road in Congress, it’s finally here: H.R. 3204, the Drug Quality and Security Act, which mandates a federal, interoperable electronic track-and-trace system, has arrived!

Bills on both sides of Congress started getting traction back in April (see our previous post here). As Spring turned to Summer, there was speculation that a bill could be passed by summer recess. Summer turned to Fall, and by this point, a bi-cameral, bi-partisan version of the bill emerged (see our previous post here). The bill was passed by voice vote in the House at the end of September, and there was hope that the Senate would pass it by the end of the fiscal year. Then, the government shutdown happened, and the bill took a back seat. However, at long last, here we are: a federal law mandating an interoperable electronic track-and-trace system is now a reality! The fully interoperable electronic track-and-trace system is set to become a reality in 10 years, but in the interim, there are deadlines to get all players in the supply chain up to speed so that in a decade, the interoperable system is ready to go.

From a brief review, it appears that the bill has passed in identical form to the bill we blogged about and outlined in September (see our summary here, and a U.S. Senate press release here). It’s hard to believe, after years of haranguing, that this has become a reality, and it appears likely this bill will soon be signed into law. As Fall gets colder, we’re warmed by knowing that if anything is frozen this Winter, for once, it won’t be track-and-trace.